Events

Device Recall MicroScan LabPro Information Manager System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beckman Coulter Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    73417
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1269-2016
  • 사례 시작날짜
    2016-02-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-01-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144164
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Medical device data system - Product Code OUG
  • 원인
    Beckman coulter is recalling the microscan labpro information manager system because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an id hold status.
  • 조치
    An Urgent Medical Device Recall Letter dated 2/11/2016 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.41. Beckman Coulter is expanding the recall that was initiated in July 2015 regarding FA-25776 for the MicroScan LabPro Information Manager System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Representative: http:www.beckmancoulter.com, (800) 677-7226 in US and Canada. Customers outside of US and Canada, are instructed to contact their local Beckman Coulter representative.

Device

Device Recall MicroScan LabPro Information Manager System
  • 모델명 / 제조번호(시리얼번호)
    not applicable
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.
  • 제품 설명
    MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 || Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. || Japan: || 10638819 LabPro v4.11 Software Update Kit || 10638820 LabPro v4.11 System Software || 10805072 LabPro MBT Non-Connect Systems v4.30 || 10805073 LabPro MBT Connect Systems v4.30 || Canada: || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit || 10638823 LabPro v4.11 Software Update Kit || 10638825 LabPro v4.11 System Software || 10638824 LabPro v4.11 Software Update Kit || Europe: || 10638824 LabPro v4.11 Software Update Kit || 10638826 LabPro v4.11 System Software || USA: || 10714149, LabPro v4.11 Software Update Kit || 10714150 LabPro v4.11 System Software || 10975000 ASM LabPro-MBT v4.40 || 10975001 ASM LabPro-MBT v4.40 for Connect || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 6000-0026 LabPro Connect v4.41 Panel Update-06 Kit || ROW: || 6000-0008 LabPro v4.41 Panel Update-06 Kit || 10638823 LabPro v4.11 Software Update Kit || 10638825 LabPro v4.11 System Software || 10638824 LabPro v4.11 Software Update Kit || 10638826 LabPro v4.11 System Software || Product Usage: || LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA